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A single-arm, prospective, multicenter cohort study to assess the 30-day continued safety and effectiveness of the AeroPace System in patients on mechanical ventilation (MV) at least 96 hours and who have not weaned. This is a study collecting real-world data in a post-market setting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lungpacer AeroPace Therapy | Other | Subject receives AeroPace therapy consisting of 60 stimulations, twice daily for a total of 120 stimulations/day, plus standard of care for weaning from mechanical ventilation including at least once daily spontaneous breathing trials. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lungpacer Diaphragm Pacing Therapy | Device | Transvenous phrenic nerve stimulation to induce diaphragm contraction. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Event Profile | All Serious Adverse Events from enrollment to study exit and device- and/or procedure-related Adverse Events until successful wean, withdrawal/death, transfer or day 30 (whichever comes first). | 30 days |
| Successful Weaning | Proportion of subjects successfully weaned by Day 30 | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Days on mechanical ventilation from time of initial placement procedure through Day 30. | 30 days | |
| Incidence of reintubation/reinstatement of MV through Day 30 | 30 days | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Megan Cotts | Contact | (612) 986-7172 | mcotts@lungpacer.com | |
| AERO-PAS Study | Contact | aero-pas@lungpacer.com |
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| Incidence of device/procedure related SAEs as compared to RESCUE 3 Treatment group subjects |
| 30 days |
| Mortality through Day 30 | 30 days |
| Incidence of tracheostomy from enrollment through Day 30 | 30 days |
| ICU/hospital days from initial placement procedure to Day 32 | 32 days |